NCT01988337

Lesion Progression After Icon Treatment in Young Adults

Double Blind Randomized Controlled Clinical Trial of Lesion Progression After Treatment With Icon vs. Placebo in Caries Lesions in Young Adults Over 36 Months

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: DMG Dental Material Gesellschaft mbH · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This is a three year single site clinical evaluation of a FDA approved (510(k):K100062) lesion penetrating resin used to infiltrate and hamper progression of proximal carious lesions. The purpose of this study is to compare lesion progression infiltrated with (Icon, Hamburg, Germany) to a similar sized lesion in the same patient treated with a placebo. The study is designed as a randomized, controlled, prospective clinical trial with a three year follow-up evaluation period. The clinical site will enroll 150 subjects (in the age range of 19 years or older) with 2 study lesions. The patients will be evaluated at six time points over a period of 3 years. Lesion status and caries risk will be monitored at 6-month intervals, while radiographic evaluation will be conducted at 12-month intervals at 1-, 2- and 3-year recall visits.

Detailed description

Introduction Dental caries is the most widespread of all diseases. It causes destruction of tooth structure by dissolving the enamel on the outside of the tooth first and then progressing into the inside of the tooth. While it is possible to use traditional dental fillings to replace diseased tooth structure, it is far better to slow down or reverse the disease process so that no fillings are needed. One of the most difficult places to use preventive or non-surgical treatment is the contact area between teeth. Recently there is evolving interest in using composites to infiltrate enamel and dentin areas that have just begun to be destroyed by caries. The infiltration technique arrests the lesion progression by sealing the porous surface and restores the damage avoiding ongoing acidic damage of tooth structure. Objective Assess the clinical efficacy s of using Icon to infiltrate initial lesions below the tooth surfaces that exist on the contact surfaces between posterior teeth as a means of stabilizing diseased tooth structure and arresting further lesion development. Materials and Methods One hundred fifty volunteers (19+ years) with two early lesions in posterior teeth will be enrolled into a clinical trial to evaluate the clinical efficacy of infiltrating the lesions as compared to current watch-and-wait approaches that are combined with good oral hygiene and fluoride application. Each subject will have a treated lesion and a control lesion. Only small early lesions without clinical signs of surface cavitation will be selected. The control lesions will be stabilized through a normal preventive regimen, while the treatment lesions will be infiltrated with a resin. Lesion status will be monitored every six months by clinical examination and as well using annual radiographs. Clinical Significance Infiltrating a caries lesion is a potential effective strategy to strengthen damaged tooth structure and to reduce caries progression without any surgical intervention.

Conditions

• Caries
• Salivary Function
• Tooth Sensitivity

Interventions

Type	Name	Description
DEVICE	Resin infiltration	The study is a split-mouth design. One tooth with a proximal caries lesion will randomly receive the infiltrating resin (Icon) while the other will receive a placebo, according to the manufactures´ instruction for Icon. In short, teeth will be isolated with a rubber dam and the tooth surface cleaned with non-fluoride prophylactic paste and pumice. The Icon material will be applied following the manufacturer's instructions and light cured, followed by polished using interproximal finishing/polishing strips (Sof Lex, 3M ESPE, St Paul, MN). Subjects will be given a letter to take to their local dentist asking them not to treat the selected lesions without informing the investigator first.
OTHER	Mock treatment	For the mock treatment the procedure will be identical to the "Resin Infiltration" intervention, with the exception that a placebo will be used. Essentially, syringes identical to the Icon materials will be supplied by DMG for the placebo procedure. The syringes will be filled with solutions having the same consistency and color as the Icon material.

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2013-11-20
• Last updated: 2022-10-04
• Results posted: 2022-10-04

Locations

1 site across 1 country: United States